(344) Interpreting Vedolizumab: Uncovering Cachexia Signal in U.S Food and Drug Administration Adverse Event Reporting System (FAERS) Database.

Background: Vedolizumab, an integrin receptor antagonist is indicated for the treatment of moderate to severe ulcerative colitis or Crohn’s disease when there is a development of treatment resistance to other medications. Signal detection and disproportionality analysis help to identify an unidentified adverse drug reaction (ADR).

Objectives: The study aimed to identify the novel signals of vedolizumab reported within the USFDA Adverse Event Reporting System (FAERS) database.

Methods: An in-depth case/non-case retrospective disproportionality analysis was conducted in the publicly available FAERS database for vedolizumab. Vedolizumab was approved by FDA in the year 2014. All the reports of vedolizumab were analyzed. The investigation delved into the USFDA adverse event reporting system database, employing the top 2 data mining algorithms in widespread use for signal detection such as Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) from the OpenVigil database. A value of PRR≥1 and ROR-1.96SE>1 was considered a positive signal.

Results: Among the total 27,634,809 FAERS reports, 54,173 were related to vedolizumab. The vedolizumab reports (45,909) were classified as serious and many fatal reactions were reported. The total number of adverse events reported for Cachexia is 17. On analysis, data mining algorithms showed the results as ROR of 3.42(2.122; 5.511) and PRR of 3.418 (2.121; 5.507). The ROR and PRR confirmed the occurrence of the adverse reaction cachexia for Vedolizumab.

Conclusions: This study revealed that Cachexia is likely to occur among patients administered with Vedolizumab. The authors conclude that healthcare practitioners should monitor for the occurrence of cachexia among patients administered with Vedolizumab. Epidemiological studies should be conducted to validate the identified novel signal among a larger population.